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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203139
Company: TWI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGESTROL ACETATE MEGESTROL ACETATE 125MG/ML SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/27/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/08/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

MEGESTROL ACETATE

SUSPENSION;ORAL; 125MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEGACE ES MEGESTROL ACETATE 125MG/ML SUSPENSION;ORAL Prescription Yes AB 021778 ENDO OPERATIONS
MEGESTROL ACETATE MEGESTROL ACETATE 125MG/ML SUSPENSION;ORAL Prescription No AB 203139 TWI PHARMS
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